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The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department

NCT01477242 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2012-01-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For this evaluation, the investigators will perform a multi-center, double-blind, placebo-controled, randomized study. The investigators assumption is that oral ondansetron prior to intramuscular ketamine will reduce the occurrence of ketamine-induced vomiting.

Conditions

  • Sedation and Analgesia
  • Side Effect of Drug

Interventions

DRUG

Ondansetron

2mg (5mL) in \< 15 kg and 4mg (10mL) in 15kg to 30kg

Sponsors & Collaborators

  • Asan Medical Center

    collaborator OTHER

  • Myongji Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Do Kyun Kim, M.D. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01477242 on ClinicalTrials.gov